SeeLuma
GUDID 04064434000117
The ophthalmic microscope is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries.
Munich Surgical Imaging GmbH
Ophthalmic surgical microscope| Primary Device ID | 04064434000117 |
| NIH Device Record Key | 877018e9-5396-43cf-bae9-aa674efdbb0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeeLuma |
| Version Model Number | V10760-01 |
| Company DUNS | 315155571 |
| Company Name | Munich Surgical Imaging GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
| Length | 1830 Millimeter |
| Depth | 840 Millimeter |
| Height | 1965 Millimeter |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04064434000117 [Primary] |
FDA Product Code
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2023-03-24 |
On-Brand Devices [SeeLuma]
| 04064434000117 | The ophthalmic microscope is a surgical microscope designed for the illumination and magnificati |
| 04064434000124 | The medical device is a surgical microscope designed for the illumination and magnification of t |
Trademark Results [SeeLuma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEELUMA 97224493 not registered Live/Pending |
Bausch + Lomb Ireland Limited 2022-01-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.